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Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.
Joyner, Michael J; Bruno, Katelyn A; Klassen, Stephen A; Kunze, Katie L; Johnson, Patrick W; Lesser, Elizabeth R; Wiggins, Chad C; Senefeld, Jonathon W; Klompas, Allan M; Hodge, David O; Shepherd, John R A; Rea, Robert F; Whelan, Emily R; Clayburn, Andrew J; Spiegel, Matthew R; Baker, Sarah E; Larson, Kathryn F; Ripoll, Juan G; Andersen, Kylie J; Buras, Matthew R; Vogt, Matthew N P; Herasevich, Vitaly; Dennis, Joshua J; Regimbal, Riley J; Bauer, Philippe R; Blair, Janis E; van Buskirk, Camille M; Winters, Jeffrey L; Stubbs, James R; van Helmond, Noud; Butterfield, Brian P; Sexton, Matthew A; Diaz Soto, Juan C; Paneth, Nigel S; Verdun, Nicole C; Marks, Peter; Casadevall, Arturo; Fairweather, DeLisa; Carter, Rickey E; Wright, R Scott.
  • Joyner MJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN. Electronic address: https://twitter.com/DrMJoyner.
  • Bruno KA; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL.
  • Klassen SA; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Kunze KL; Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ.
  • Johnson PW; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.
  • Lesser ER; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.
  • Wiggins CC; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Senefeld JW; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Klompas AM; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Hodge DO; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.
  • Shepherd JRA; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Rea RF; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.
  • Whelan ER; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL.
  • Clayburn AJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Spiegel MR; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.
  • Baker SE; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Larson KF; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Ripoll JG; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Andersen KJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Buras MR; Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ.
  • Vogt MNP; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Herasevich V; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Dennis JJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Regimbal RJ; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Bauer PR; Department of Internal Medicine, Division of Pulmonary and Critical Care, Mayo Clinic, Rochester, MN.
  • Blair JE; Department of Internal Medicine, Division of Infectious Diseases, Mayo Clinic, Phoenix, AZ.
  • van Buskirk CM; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
  • Winters JL; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
  • Stubbs JR; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
  • van Helmond N; Department of Anesthesiology, Cooper Medical School of Rowan University, Cooper University Health Care, Camden, NJ.
  • Butterfield BP; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Sexton MA; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Diaz Soto JC; Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
  • Paneth NS; Departments of Epidemiology and Biostatistics and Pediatrics and Human Development, College of Human Medicine, Michigan State University, East Lansing.
  • Verdun NC; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
  • Marks P; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
  • Casadevall A; Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
  • Fairweather D; Department of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL.
  • Carter RE; Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.
  • Wright RS; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN; Department of Human Research Protection Program, Mayo Clinic, Rochester, MN.
Mayo Clin Proc ; 95(9): 1888-1897, 2020 09.
Article in English | MEDLINE | ID: covidwho-654169
Semantic information from SemMedBD (by NLM)
1. hospitalized patients LOCATION_OF Plasma
Subject
hospitalized patients
Predicate
LOCATION_OF
Object
Plasma
2. Metric (substance) TREATS hospitalized patients
Subject
Metric (substance)
Predicate
TREATS
Object
hospitalized patients
3. Plasma PART_OF hospitalized patients
Subject
Plasma
Predicate
PART_OF
Object
hospitalized patients
4. hospitalized patients LOCATION_OF Plasma
Subject
hospitalized patients
Predicate
LOCATION_OF
Object
Plasma
5. Metric (substance) TREATS hospitalized patients
Subject
Metric (substance)
Predicate
TREATS
Object
hospitalized patients
6. Plasma PART_OF hospitalized patients
Subject
Plasma
Predicate
PART_OF
Object
hospitalized patients
ABSTRACT

OBJECTIVE:

To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients. PATIENTS AND

METHODS:

From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma.

RESULTS:

The incidence of all serious adverse events was low; these included transfusion reactions (n=78; <1%), thromboembolic or thrombotic events (n=113; <1%), and cardiac events (n=677, ~3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%).

CONCLUSION:

These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Patient Safety Type of study: Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: North America Language: English Journal: Mayo Clin Proc Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Patient Safety Type of study: Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: North America Language: English Journal: Mayo Clin Proc Year: 2020 Document Type: Article